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Recall Observatory FDA recall evidence

Device product

ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,

Z-0527-2016

November 16, 2015

Class III

Product summary

Firm
Ameditech Inc
Event
Event 72651
Status
Terminated
Classification
Class III
Quantity
2,675 kits
Official record key
device-enforcement:Z-0527-2016

Official wording

Reason: Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

Code information: 141955 142043 142055 142161 142513 142600 142824 142937 142938 142969 143143 143149 143234 143513 143758 143806 143807 144441 152035 152042 152075 152911 153237 153240 153523

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.